| アブストラクト | BACKGROUND: Fabry disease (FD), an X-linked lysosomal disorder, is marked by a lack of alpha-galactosidase A (alpha-Gal A). Agalsidase beta, a recombinant form of alpha-Gal A, is fundamental to enzyme replacement therapy for FD but requires close monitoring for adverse events (AEs). RESEARCH DESIGN AND METHODS: This study retrospectively analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) database for agalsidase beta-related AEs. Disproportionality analysis was used for data analysis. RESULTS: A total of 7,611 AE reports for agalsidase beta were analyzed. The most common AEs included pyrexia, pain, chills, malaise, and nausea. Several system organ classes including Cardiac Disorders, General Disorders and Administration Site Conditions, and Vascular Disorders, showed positive signals. Subgroup analysis by gender revealed differences in AE reporting, with males exhibiting a higher reporting odds ratio for certain preferred terms such as Renal Transplant and Drug Specific Antibody Present. CONCLUSION: The FAERS database analysis of agalsidase beta AEs identified a significant number of cardiovascular, renal, and cerebrovascular system-related reports. While agalsidase beta is generally well-tolerated, the study underscores the necessity for gender-specific treatment approaches due to the higher incidence of certain AEs in males. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2024/12/22 |
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| 投稿者 | Xie, Wen-Long; Li, Hou-Hong; Li, Di; Li, Ju-Yi; Deng, Ai-Ping |
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| 組織名 | Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College,;Huazhong University of Science and Technology, Wuhan, China.;Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province,;Tongji Medical College, Huazhong University of Science and Technology, Wuhan,;China.;Department of Pharmacy, Traditional Chinese and Western Medicine Hospital of;Wuhan, Tongji Medical College, Huazhong University of Science and Technology,;Wuhan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39707961/ |
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